Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide

Surgical Procedure, Unspecified Clinical Trial

— BSO  

Official title:

Development and Pilot Test of an Elective Bilateral Salpingo-Oophorectomy (BSO) Decision Support Guide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369654
• Other study ID #: 10-03107
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: June 2, 2015
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The investigators propose to conduct formative research to gain an understanding of patients' needs and desires regarding elective Bilateral Salpingo-Oophorectomy (BSO) decision making, and to develop and pilot test a BSO Decision Support Guide, in preparation for a randomized, controlled trial of the effect of this decision aid on decision quality and use of BSO. The proposed study will consist of 3 phases. In phase 1, the investigators plan to conduct focus groups among women who have had a hysterectomy with or without bilateral salpingo-oophorectomy (BSO) to gain an understanding of what they understood about BSO and its possible outcomes at the time of their hysterectomy and what they would have liked to have known, the extent and manner in which they were included in decision making regarding BSO, and how they feel about the decision now. The investigators also will collect qualitative data from women who are scheduled for hysterectomy and currently facing the decision whether or not to undergo elective BSO. In phase 2, the investigators plan to create a BSO Decision Support Guide using information obtained from the literature, from our formative research, and the experience of providers who have counseled women about this choice. In phase 3, the investigators plan to pilot test the BSO Decision Support Guide among women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and usability for patients and their providers and to prepare for a randomized study of its impact on decision quality and use of BSO. 62 women who are scheduled to undergo hysterectomy for a non-cancerous uterine condition will participate in the pilot study. These women will participate in a baseline interview, during which they will be provided access to the BSO Decision Support Guide, and 2 follow up telephone interviews (one as they are making their final BSO decision and a second after they have undergone and recovered from their hysterectomy (with or without BSO). Data will be used to generate the final version of the Decision Support Guide, to finalize evaluation measures for future studies of the effectiveness of the guide, and to determine effect sizes for the outcomes of knowledge, BSO use, decision satisfaction and decisional conflict.

Description:

Specific Aim 1) Conduct formative research to assess how sociodemographically diverse women who will be undergoing hysterectomy for non-cancerous conditions view elective BSO and to assess their information needs and desires regarding shared decision making in this context.

Specific Aim 2) Create a BSO Decision Support Guide using information obtained from the literature, from our formative research, and the experience of providers who have counseled women about this choice.

Specific Aim 3) Pilot test the BSO Decision Support Guide among women scheduled to undergo hysterectomy for benign conditions to assess its usefulness and usability for patients and their providers and to prepare for a randomized study of its impact on decision quality and use of BSO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• Premenopausal defined as having at least one menses in the 3 months prior to surgery;

• age >40 years;

• Plans to undergo an elective hysterectomy for symptomatic fibroids, abnormal bleeding, pelvic pain, or pelvic organ prolapse;

• Plans to undergo hysterectomy via any route (laparoscopic, laparotomy, or vaginal;

• speaks English

Exclusion Criteria:

• having personal or family history of breast and/or ovarian cancer or a known breast cancer gene (BRCA) mutation;

• Known or suspected adnexal mass by exam or radiologic imaging;

• Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis;

• Diagnosis of coronary heart disease (CHD) or osteoporosis;

• Cannot speak English;

• Less than 40 years of age.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Behavioral:
• Computerized decision aid with 1 type of value clarification
Women will be instructed to view a computerized BSO decision support guide.

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with Intervention	After study participants participate in a baseline interview, during which they will be provided access to the BSO Decision Support guide, they will receive 2 follow up telephone interviews (one as they are making their final BSO decision and a second after they have undergone and recovered from their hysterectomy (with or without BSO)	6 months	No
Secondary	BSO Decisional conflict, regret, anxiety	In the 2nd follow up telephone interview we will ask how helpful was the BSO Decision Support Guide, and if they have any conflicts or regrets with the decisions made.	6 months	No